[PART I. FINANCIAL INFORMATION](index=7&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section details the company's unaudited financial statements, management's analysis, market risk disclosures, and internal controls [Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited financial statements, highlighting increased cash from IPO and a wider net loss due to R&D expenses [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This section details the company's financial position, showing significant increases in cash and equity post-IPO Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $588,335 | $352,447 | | Total current assets | $594,738 | $359,133 | | Total assets | $690,695 | $450,988 | | **Liabilities & Equity** | | | | Total liabilities | $185,308 | $163,638 | | Redeemable convertible preferred stock | $0 | $540,857 | | Total stockholders' equity (deficit) | $505,387 | $(253,507) | - Following the IPO, all redeemable convertible preferred stock, previously valued at **$540.9 million**, was converted into common stock, **significantly strengthening the stockholders' equity position**[22](index=22&type=chunk)[30](index=30&type=chunk)[96](index=96&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) This section outlines the company's financial performance, showing a widened net loss driven by increased R&D expenses Statement of Operations Highlights (in thousands) | Account | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Research and development | $57,185 | $17,813 | | General and administrative | $8,603 | $4,075 | | Change in fair value of contingent consideration | $14,020 | $(915) | | **Loss from operations** | **$(79,808)** | **$(21,063)** | | **Net loss** | **$(76,588)** | **$(19,880)** | | Net loss per share, basic and diluted | $(1.03) | $(1.44) | - The net loss **increased significantly** year-over-year, primarily due to a **more than threefold increase** in R&D expenses and a **$14.0 million expense** related to the change in fair value of contingent consideration[26](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This section presents the company's cash flow activities, highlighting substantial cash inflow from financing activities Cash Flow Highlights (in thousands) | Activity | Three Months Ended Mar 31, 2025 | Three Months Ended Mar 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(54,342) | $(15,772) | | Net cash used in investing activities | $(7) | $0 | | Net cash provided by financing activities | $288,559 | $42,872 | | **Net increase in cash and cash equivalents** | **$235,888** | **$27,070** | - Financing activities in Q1 2025 were **dominated by $288.5 million** in net proceeds from the company's IPO[33](index=33&type=chunk)[168](index=168&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) This section details accounting policies, IPO proceeds, liquidity, acquisition liabilities, and licensing agreements - In February 2025, the company completed its IPO, selling **17,569,444 shares of common stock** and receiving net proceeds of **$288.4 million**[38](index=38&type=chunk) - As of March 31, 2025, the company had cash and cash equivalents of **$588.3 million** and believes this is **sufficient to fund operations for at least 12 months** from the report's issuance date[40](index=40&type=chunk) - The fair value of contingent consideration liability from the Zihipp acquisition **increased** from **$107.0 million** to **$121.0 million** during Q1 2025, mainly due to an **increased probability** of achieving development milestones[82](index=82&type=chunk)[84](index=84&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of financial condition, results of operations, and liquidity, emphasizing pipeline progress and IPO impact [Business Overview and Pipeline](index=23&type=section&id=Business%20Overview%20and%20Pipeline) This section outlines Metsera's clinical-stage biopharmaceutical focus on obesity and metabolic diseases, detailing its pipeline and key milestones - The company's **lead programs and anticipated milestones** include: - **MET-097i (GLP-1 RA):** Phase 2b ongoing, with preliminary readouts expected mid-2025 through early 2026. - **MET-233i (Amylin Analog):** Phase 1 ongoing, with preliminary readouts expected in mid and late 2025. - **Oral Peptide Platform:** Phase 1 trials for MET-097o and MET-224o planned for mid-2025, with a lead candidate readout expected late 2025[119](index=119&type=chunk)[130](index=130&type=chunk) - The company completed its IPO in early 2025, raising net proceeds of $288.4 million[38](index=38&type=chunk)[129](index=129&type=chunk) - Construction of new manufacturing facilities in India with partner Amneal Pharmaceuticals is **on track** to support future peptide synthesis and sterile fill-finish needs[128](index=128&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) This section compares quarterly financial results, highlighting a significant increase in net loss due to higher R&D and G&A expenses Operating Expense Comparison (in thousands) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Research and development | $57,185 | $17,813 | $39,372 | | General and administrative | $8,603 | $4,075 | $4,528 | | Change in fair value of contingent consideration | $14,020 | $(915) | $14,935 | - The increase in R&D expenses was **driven by the ramp-up of development** for the company's portfolio of injectable and oral programs, including MET-097i, MET-233i, and the oral peptide platform[147](index=147&type=chunk)[148](index=148&type=chunk) - The increase in G&A expenses was **primarily due to** higher personnel-related costs (**$2.1M**), stock-based compensation (**$1.2M**), and costs associated with being a public company (**$0.7M**)[149](index=149&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's funding, current cash position, and future capital needs, including significant contingent payment obligations - As of March 31, 2025, the company had cash and cash equivalents of **$588.3 million** and an **accumulated deficit of $333.7 million**[156](index=156&type=chunk) - Management estimates that existing cash and cash equivalents will be **sufficient to fund projected operating expenses and capital expenditure requirements into 2027**[130](index=130&type=chunk)[161](index=161&type=chunk) - The company has **significant future contingent payment obligations**, including **up to $150 million** in development, regulatory, and commercial milestones for the Zihipp acquisition, and **up to $460.5 million** in milestones plus royalties for the D&D license agreements[173](index=173&type=chunk)[179](index=179&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is therefore not required to provide the information under this item - As a smaller reporting company, Metsera is **exempt** from providing quantitative and qualitative disclosures about market risk[203](index=203&type=chunk) [Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, with the participation of the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of March 31, 2025 - Management concluded that disclosure controls and procedures were **effective** as of March 31, 2025[205](index=205&type=chunk) - There were **no material changes** in the company's internal control over financial reporting during the quarter ended March 31, 2025[206](index=206&type=chunk) [PART II. OTHER INFORMATION](index=38&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section covers legal proceedings, comprehensive risk factors, and details on equity sales and use of proceeds [Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently subject to any material legal proceedings - As of the report date, the company is **not a party to any material legal proceedings**[209](index=209&type=chunk) [Risk Factors](index=38&type=section&id=Item%201A.%20Risk%20Factors) This section outlines material risks, including financial position, product development, third-party reliance, commercialization, and intellectual property [Risks Related to Financial Position and Capital Requirements](index=38&type=section&id=Risks%20Related%20to%20Financial%20Position%20and%20Capital%20Requirements) This section details risks associated with the company's limited operating history, accumulated losses, and future capital needs - The company is a clinical-stage entity with a **limited operating history**, no commercial products, and has **incurred significant operating losses** since inception, with an **accumulated deficit of $333.7 million** as of March 31, 2025[211](index=211&type=chunk)[212](index=212&type=chunk) - The company will require **substantial additional capital** to finance its operations. A failure to obtain this capital could force it to delay, limit, or terminate its development programs[214](index=214&type=chunk) [Risks Related to Development and Regulatory Approval](index=40&type=section&id=Risks%20Related%20to%20Development%20and%20Regulatory%20Approval) This section addresses risks concerning product candidate development, regulatory approval uncertainties, and potential adverse side effects - The company's success is **entirely dependent on its product candidates**, which are in early stages of development and face a **highly uncertain, lengthy, and expensive process** with no guarantee of success[220](index=220&type=chunk) - The regulatory approval processes of the FDA and other authorities are **unpredictable**. The company's injectable product candidates are expected to be regulated as combination products, which may require **additional time and coordination** for review[257](index=257&type=chunk)[263](index=263&type=chunk) - Use of product candidates could be associated with **adverse side effects**, which could delay or preclude regulatory approval, or limit the commercial profile if approved. The labels for its GLP-1 RA candidates may require a **boxed warning** for thyroid C-cell tumors, similar to competitors[243](index=243&type=chunk)[251](index=251&type=chunk) [Risks Related to Reliance on Third Parties](index=51&type=section&id=Risks%20Related%20to%20Reliance%20on%20Third%20Parties) This section highlights risks stemming from reliance on third-party CROs, manufacturers, and licensing agreements - The company **relies on third parties (CROs)** to conduct clinical trials and on third-party manufacturers for its clinical supply, which exposes it to **risks of non-performance, regulatory non-compliance (GCP/cGMP), and supply interruptions**[280](index=280&type=chunk)[283](index=283&type=chunk) - The company **depends on license and collaboration agreements** (e.g., Amneal, D&D, Imperial College). Termination of these agreements or failure to meet obligations could result in the **loss of critical intellectual property and development rights**[294](index=294&type=chunk) [Risks Related to Commercialization](index=54&type=section&id=Risks%20Related%20to%20Commercialization) This section covers risks related to market competition, achieving market acceptance, reimbursement, and building sales capabilities - The company faces **significant competition** from large, well-resourced pharmaceutical companies with approved and established therapies for obesity and overweight, such as Novo Nordisk (Wegovy) and Eli Lilly (Zepbound)[302](index=302&type=chunk) - Commercial success will depend on achieving **market acceptance** and securing **adequate coverage and reimbursement** from governmental and private payors, which is uncertain[309](index=309&type=chunk)[311](index=311&type=chunk) - The company currently has **no marketing, sales, or distribution capabilities** and will need to invest significant resources to build these functions or rely on partners[331](index=331&type=chunk) [Risks Related to Intellectual Property](index=70&type=section&id=Risks%20Related%20to%20Intellectual%20Property) This section discusses risks concerning patent protection, reliance on licenses, and potential intellectual property infringement claims - The company's success **depends on its ability to obtain, maintain, and enforce patent protection** for its product candidates, which is an expensive and uncertain process[385](index=385&type=chunk)[386](index=386&type=chunk) - The company **relies on licenses from third parties** (Imperial College, D&D). Failure to comply with license obligations could result in the **loss of rights to key intellectual property**[394](index=394&type=chunk) - The company may face **third-party claims of intellectual property infringement**, which could be expensive, time-consuming, and potentially prevent or delay the commercialization of its products[429](index=429&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=88&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period. It confirms that there has been no material change in the intended use of proceeds from its February 2025 IPO, which were registered under the Securities Act - There were **no unregistered sales of equity securities** during the quarter ended March 31, 2025[483](index=483&type=chunk) - The company completed its IPO on February 3, 2025, selling **17,569,444 shares of common stock at $18.00 per share**. There has been **no material change** in the expected use of the net proceeds[484](index=484&type=chunk)[486](index=486&type=chunk)

[Report Overview](index=1&type=section&id=Report%20Overview) Metsera's Q1 2025 performance highlights a successful IPO and steady progress toward its clinical milestones [First Quarter 2025 Highlights](index=1&type=section&id=First%20Quarter%202025%20Highlights) Metsera reported strong Q1 2025 execution, a successful IPO securing funding into 2027, and progress on clinical milestones - Successfully completed a **$316 million IPO** in Q1 2025, with sufficient cash and cash equivalents of **$588 million** to fund operations into **2027**[2](index=2&type=chunk)[4](index=4&type=chunk) - The company is on track to deliver on key **2025 clinical milestones**, including data releases for MET-233i, MET-097i, and other programs[1](index=1&type=chunk)[4](index=4&type=chunk) [Pipeline Highlights and Upcoming Milestones](index=1&type=section&id=Pipeline%20Highlights%20and%20Upcoming%20Milestones) The company is advancing its clinical pipeline, with key data readouts expected for its injectable and oral programs in 2025 [MET-097i: Injectable GLP-1 RA](index=1&type=section&id=MET-097i%3A%20Injectable%20GLP-1%20RA) The Phase 2b program for the monthly injectable GLP-1 RA is progressing, with key data expected mid-2025 to inform a Phase 3 start - MET-097i is a fully biased, **monthly, ultra-long acting GLP-1 receptor agonist**[1](index=1&type=chunk)[5](index=5&type=chunk) - The **VESPER Phase 2b program** consists of three trials (VESPER-1, -2, -3) to evaluate MET-097i's efficacy and tolerability[5](index=5&type=chunk) VESPER Phase 2b Program Overview | Trial | Population | Primary Endpoint | Expected Data Release | | :--- | :--- | :--- | :--- | | **VESPER-1** | Obesity/overweight (no T2D) | Weight loss at 28 weeks | Mid-2025 | | **VESPER-2** | Obesity/overweight with T2D | Weight loss at 28 weeks | Early 2026 | | **VESPER-3** | Obesity/overweight (no T2D) | Weight loss with monthly doses | Year-end 2025 / Early 2026 | - Pending results from VESPER-1, the company plans to initiate a **Phase 3 program in late 2025**[5](index=5&type=chunk) [MET-233i: Injectable Amylin Analog](index=2&type=section&id=MET-233i%3A%20Injectable%20Amylin%20Analog) Phase 1 trials for the monthly injectable amylin analog are ongoing, with initial monotherapy and combination data expected in 2025 - MET-233i is a **monthly, ultra-long acting, subcutaneously injectable amylin analog** currently in Phase 1 trials[6](index=6&type=chunk)[7](index=7&type=chunk) - Upcoming data readouts include **preliminary 5-week monotherapy data in Q2 2025**, followed by 12-week monotherapy and 5-week co-administration data in late 2025[6](index=6&type=chunk)[7](index=7&type=chunk) [Oral Peptide Platform (MET-097o & MET-224o)](index=2&type=section&id=Oral%20Peptide%20Platform) The oral drug pipeline is advancing with Phase 1 trials for two candidates starting mid-2025, with initial data expected by year-end - The oral GLP-1 RA program includes **MET-097o and MET-224o**[6](index=6&type=chunk)[7](index=7&type=chunk) - Development of **MET-097o has been accelerated** due to promising preclinical oral exposure data[7](index=7&type=chunk) - **Phase 1 trials** for both oral candidates are planned to start in **mid-2025**, with preliminary 4-week data for the selected lead candidate expected in **late 2025**[6](index=6&type=chunk)[7](index=7&type=chunk) [Financial Results](index=3&type=section&id=First%20Quarter%202025%20Financial%20Results) The company's Q1 2025 financials show a widened net loss due to increased R&D spending, offset by a strong cash position post-IPO [Financial Performance Summary](index=3&type=section&id=Financial%20Performance%20Summary) Q1 2025 net loss grew to $76.6 million on higher R&D costs, while the post-IPO cash balance of $588.3 million ensures a runway into 2027 - Cash and cash equivalents increased to **$588.3 million** as of March 31, 2025, projecting a financial runway into **2027**[8](index=8&type=chunk) Q1 Financial Highlights | Financial Metric (Q1) | 2025 | 2024 | Change Driver | | :--- | :--- | :--- | :--- | | **R&D Expenses** | $57.2M | $17.8M | Increased preclinical, clinical, and manufacturing costs | | **G&A Expenses** | $8.6M | $4.1M | Increased personnel-related expenses | | **Net Loss** | $76.6M | $19.9M | Higher operating expenses and change in fair value of contingent consideration | [Corporate Updates](index=3&type=section&id=Corporate%20Updates) The company is advancing its manufacturing collaboration with Amneal and has strengthened its leadership team and board [Manufacturing Updates](index=3&type=section&id=Manufacturing%20Updates) The strategic manufacturing partnership with Amneal is on track, with new dedicated facilities under construction in India - The strategic collaboration with Amneal is progressing, with construction of new facilities in India featuring **Metsera-dedicated lines** for peptide synthesis and sterile fill-finish manufacturing[12](index=12&type=chunk) - Metsera plans to work with Amneal to optimize its **commercial manufacturing footprint** across Amneal's US and global network[12](index=12&type=chunk) [Organizational Updates](index=3&type=section&id=Organizational%20Updates) Metsera strengthened its governance and legal functions with key appointments to its Board of Directors and executive team - **Jon P. Stonehouse**, CEO of BioCryst Pharmaceuticals, was appointed to the **Board of Directors** as a Class III director and a member of the Audit Committee[13](index=13&type=chunk) - **Matthew Lang** was appointed as **Chief Legal Officer and Secretary**, bringing experience from roles at Lyell Immunopharma and Myovant Sciences[14](index=14&type=chunk) [Financial Statements](index=6&type=section&id=Financial%20Statements) The condensed consolidated financial statements reflect a strengthened balance sheet and increased operating expenses for Q1 2025 [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) The balance sheet shows total assets grew to $690.7 million and stockholders' equity became positive, driven by IPO proceeds Condensed Consolidated Balance Sheets | (in thousands) | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | $594,738 | $359,133 | | *Cash and cash equivalents* | *$588,335* | *$352,447* | | **Total Assets** | **$690,695** | **$450,988** | | **Total Current Liabilities** | $90,741 | $67,307 | | **Total Liabilities** | **$185,308** | **$163,638** | | **Total Stockholders' Equity (Deficit)** | **$505,387** | **($253,507)** | [Condensed Consolidated Statement of Operations](index=7&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENT%20OF%20OPERATIONS) The Q1 2025 statement of operations reveals a net loss of $76.6 million, widened by a significant year-over-year rise in R&D expenses Condensed Consolidated Statement of Operations | (in thousands, except per share data) | For the three months ended March 31, 2025 | For the three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $57,185 | $17,813 | | General and administrative | $8,603 | $4,075 | | Total operating expenses | $79,808 | $21,063 | | **Loss from operations** | **($79,808)** | **($21,063)** | | **Net loss** | **($76,588)** | **($19,880)** | | **Net loss per share, basic and diluted** | **($1.03)** | **($1.44)** |

Core Insights - Metsera, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation medicines for obesity and metabolic diseases [3] - The CEO, Whit Bernard, will present at the Bank of America 2025 Global Healthcare Conference on May 14, 2025 [1] - A live webcast of the presentation will be available on Metsera's website [2] Company Overview - Metsera was founded in 2022 and is based in New York City [3] - The company is advancing a portfolio of oral and injectable therapies targeting obesity and metabolic diseases, including incretin and non-incretin therapies [3] - Metsera aims to address multiple therapeutic targets to meet the evolving needs of weight loss treatments [3] Investor Information - Metsera utilizes its website as a distribution channel for material information, which is accessible through the Investors & News section [4] - Investors can sign up for email alerts to receive updates about the company [4]

Part I [Business Overview](index=8&type=section&id=Item%201.%20Business) Metsera is a clinical-stage biotechnology company developing next-generation injectable and oral NuSH analog peptides to treat obesity and related conditions, leveraging proprietary platforms - Metsera is a clinical-stage biotechnology company developing next-generation injectable and oral NuSH analog peptides to treat obesity, overweight, and related conditions, targeting a market of approximately **2.5 billion** people worldwide[18](index=18&type=chunk) - The company utilizes three proprietary platforms: the **MINT** peptide library, the **HALO** half-life extending platform, and the **MOMENTUM** oral delivery platform to develop its product candidates[18](index=18&type=chunk)[54](index=54&type=chunk) [Our Strategy](index=10&type=section&id=Our%20Strategy) Metsera's strategy focuses on advancing lead injectable and oral candidates for obesity, leveraging proprietary platforms and strategic manufacturing partnerships - Advance **MET-097i** as a monthly injectable GLP-1 RA monotherapy for obesity, with ongoing Phase 2b trials (VESPER-1, VESPER-2) and a planned monthly dosing trial (VESPER-3)[27](index=27&type=chunk)[28](index=28&type=chunk) - Develop **MET-233i**, an ultra-long acting amylin analog, for use as a monotherapy and in combination with **MET-097i**, with a Phase 1 trial ongoing[28](index=28&type=chunk) - Utilize the **MOMENTUM** platform to advance oral GLP-1 RA candidates (**MET-224o**, **MET-097o**) and other NuSH pathways to provide injectable-like performance with oral administration[28](index=28&type=chunk) - Establish scaled manufacturing through a strategic supply agreement with Amneal to build a dedicated facility, aiming to address potential market shortages and ensure commercial launch capacity[29](index=29&type=chunk) [The Obesity and Overweight Market and Treatment Landscape](index=14&type=section&id=The%20Obesity%20and%20Overweight%20Market%20and%20Treatment%20Landscape) The global obesity market is substantial and growing, with current GLP-1 RA therapies facing limitations in dosing, tolerability, and manufacturing, indicating a significant unmet need - Obesity and overweight affect approximately **2.5 billion** adults globally and are projected to impact nearly half of Americans by 2030[31](index=31&type=chunk) - The global GLP-1 RA market was approximately **$36 billion** in 2023 and is estimated to reach **$170 billion** by 2030[41](index=41&type=chunk) - Key limitations of current approved GLP-1 RA treatments include the need for weekly injections, prolonged titration, poor tolerability (nausea, vomiting), insufficient weight loss for many patients, and manufacturing scalability challenges leading to drug shortages[42](index=42&type=chunk)[43](index=43&type=chunk)[44](index=44&type=chunk) [Our Pipeline and Programs](index=27&type=section&id=Our%20Pipeline%20and%20Programs) Metsera's pipeline features advanced injectable and oral NuSH analog peptides, including the lead monthly GLP-1 RA MET-097i in Phase 2b, and next-generation programs Metsera's Development Pipeline | STRATEGY | PROGRAM | DISCOVERY IND / CTA-ENABLING | PHASE I | PHASE 2 | PHASE 3 | ANTICIPATED MILESTONES | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **FULLY BIASED, MONTHLY GLP-I RA** | MET-097i (Fully Biased GLP-1 RA) | | | Phase 2b ongoing | | Phase 2b weekly preliminary readout mid 2025. Phase 2b monthly preliminary readout year end 2025 / early 2026. | | **MONTHLY AMYLIN AGONISM + GLP-I RA** | MET-233i (Amylin Analog) | | Phase 1 ongoing | | | Phase 1 preliminary readout mid 2025 | | | MET-233i + MET-097i | | | | | Phase 1 preliminary readout late 2025 | | **ORAL PEPTIDE PLATFORM (MOMENTUM)** | MET-2240 / MET-0970 (Fully Biased GLP-1 RAs) | IND-enabling studies ongoing | | | | Phase 1/2 preliminary readout of MET-2240 late 2025 | | | MET-002o (GLP-1 RA) | | Phase 1 ongoing | | | | | **NEXT-GENERATION PROGRAMS** | MET-034i (GIP RA) | IND-enabling studies ongoing | | | | Phase 1 preliminary readout late 2025 | | | MET-067i (Glucagon Analog) | IND-enabling studies ongoing | | | | | | | MET-815i (MET-097i prodrug) | IND-enabling studies ongoing | | | | | - **MET-097i**, a monthly injectable GLP-1 RA, demonstrated a half-life of **15-16 days** and achieved **11.3%** placebo-adjusted body weight loss after 12 weekly doses of **1.2 mg** in a Phase 1/2 trial. A Phase 2b trial (VESPER-1) is fully enrolled with data expected mid-2025[20](index=20&type=chunk)[67](index=67&type=chunk)[145](index=145&type=chunk) - **MET-233i** is an ultra-long acting amylin analog in a Phase 1 trial, with preliminary data expected mid-2025. It is designed for monotherapy or combination with **MET-097i**[21](index=21&type=chunk)[155](index=155&type=chunk) - Oral candidates **MET-224o** and **MET-097o** are being developed using the **MOMENTUM** platform. A formulation optimization trial with prototype **MET-002** is ongoing in Canada, with preliminary data for **MET-224o** expected in late 2025[23](index=23&type=chunk)[188](index=188&type=chunk)[209](index=209&type=chunk) [Licensing, Partnerships and Collaborations](index=62&type=section&id=Licensing%2C%20Partnerships%20and%20Collaborations) Metsera has strategic licensing agreements with D&D Pharmatech and Imperial College for key product candidates, alongside a crucial supply partnership with Amneal for manufacturing - Entered a license agreement with D&D Pharmatech for exclusive worldwide rights to develop and commercialize certain oral peptide agonists, including **MET-002** and **MET-224o**. The deal includes a **$10 million** upfront payment, potential development and regulatory milestones up to **$52 million** per product, and tiered royalties[231](index=231&type=chunk)[236](index=236&type=chunk) - Acquired an exclusive license from Imperial College (via the Zihipp acquisition) for NuSH analog peptides including **MET-097i** and **MET-233i**. Terms include up to **£20.5 million** in milestones and tiered low-single-digit royalties on net sales[242](index=242&type=chunk)[244](index=244&type=chunk) - Signed a Development and Supply Agreement with Amneal, designating them as the preferred supplier. Metsera will provide up to **$100 million** to support construction of new manufacturing facilities in India, for which it will receive rebates on manufactured units[247](index=247&type=chunk)[250](index=250&type=chunk) [Intellectual Property](index=70&type=section&id=Intellectual%20Property) Metsera's intellectual property strategy combines owned and in-licensed patents, with **42 issued patents** and **127 pending applications** covering key product candidates until 2040-2046 - As of March 7, 2025, Metsera owned or licensed **42 issued patents** and **127 pending patent applications** worldwide. There are no issued patents covering the product candidates currently in development[256](index=256&type=chunk) Key Patent Portfolio Expiration Outlook | Product Candidate | Patent Family Status | Expected Expiration (excluding extensions) | | :--- | :--- | :--- | | **MET-097i** | Owned & In-licensed (IP2IPO) | 2045 & 2041 | | **MET-233i** | In-licensed (IP2IPO) | 2043 | | **MET-233i/MET-097i Combo** | Owned | 2045 | | **MET-067i** | In-licensed (IP2IPO) | 2040 | | **MET-034i** | In-licensed (IP2IPO) | 2044 or 2045 | | **MET-815i** | Owned | 2046 | | **MET-224o** | Jointly owned (D&D) | 2045 | | **MET-002** | In-licensed (D&D) | 2041 & 2042 | [Manufacturing](index=74&type=section&id=Manufacturing) Metsera's manufacturing strategy leverages **HALO** and **MOMENTUM** platforms for scalability, relying on CMOs for clinical supply and a strategic partnership with Amneal for commercial production - The company's technology platforms (**HALO** and **MOMENTUM**) are designed to improve scalability by increasing half-life and bioavailability, thereby reducing the required API for both oral and injectable products[268](index=268&type=chunk)[269](index=269&type=chunk) - Metsera relies on third-party CMOs for current clinical trial manufacturing and has a strategic collaboration with Amneal to build new peptide synthesis and sterile fill-finish facilities in India for future clinical and commercial supply[271](index=271&type=chunk)[272](index=272&type=chunk) [Government Regulation](index=76&type=section&id=Government%20Regulation) Metsera's products face extensive FDA and global regulation, including complex pathways for drugs, biologics, and combination products, alongside healthcare laws impacting pricing and reimbursement - The company's product candidates are regulated by the FDA under the FDCA and PHSA, requiring extensive preclinical and clinical trials to demonstrate safety and efficacy before an NDA (drug) or BLA (biologic) can be approved[280](index=280&type=chunk) - Biologics approved under a BLA may be eligible for **12 years** of reference product exclusivity in the U.S., a potential advantage over the shorter exclusivity periods for drugs[25](index=25&type=chunk)[315](index=315&type=chunk) - Some product candidates are combination products (e.g., drug-biologic or biologic-device), which may require coordinated review by different FDA centers and could lead to additional regulatory complexities and delays[304](index=304&type=chunk)[307](index=307&type=chunk)[398](index=398&type=chunk) - The business is subject to healthcare cost-containment measures, including the Affordable Care Act (ACA) and the Inflation Reduction Act (IRA), which empowers Medicare to negotiate drug prices and imposes inflation-based rebates[325](index=325&type=chunk)[327](index=327&type=chunk) [Risk Factors](index=97&type=section&id=Item%201A.%20Risk%20Factors) The company faces substantial risks including limited operating history, significant financial losses, uncertain clinical development, reliance on third parties, intense competition, and intellectual property challenges - **Financial Risk:** The company is a clinical-stage entity with a limited operating history, no commercial products, and has incurred significant operating losses (**$209.1 million** in 2024). It will require substantial additional capital to fund operations[340](index=340&type=chunk)[341](index=341&type=chunk) - **Development and Regulatory Risk:** The company's business depends entirely on the success of its product candidates, which are in early stages of development. Clinical development is a lengthy, expensive, and uncertain process with a high historical failure rate[351](index=351&type=chunk)[356](index=356&type=chunk) - **Third-Party Reliance:** Metsera relies on third parties like CROs to conduct clinical trials and on partners like Amneal for manufacturing, which increases risks related to quality control, supply chain, and timeline adherence[411](index=411&type=chunk)[414](index=414&type=chunk) - **Commercialization and Competition Risk:** The company faces intense competition from large pharmaceutical companies with established obesity treatments (e.g., Wegovy, Zepbound). Commercial success will depend on market acceptance, pricing, and reimbursement from payors[428](index=428&type=chunk)[435](index=435&type=chunk)[437](index=437&type=chunk) - **Intellectual Property Risk:** The company's ability to protect its technology through patents and trade secrets is critical. It faces risks of its patents not being granted, being challenged, or being circumvented by competitors[513](index=513&type=chunk)[514](index=514&type=chunk) [Cybersecurity](index=195&type=section&id=Item%201C.%20Cybersecurity) Metsera's cybersecurity program, based on **NIST 800-53** and overseen by the Board, has not experienced material incidents to date, but acknowledges inherent cyber threat risks - The company's cybersecurity program is designed and assessed based on the **NIST 800-53** framework and is integrated into its overall enterprise risk management[609](index=609&type=chunk)[610](index=610&type=chunk) - The Board of Directors oversees the cybersecurity program, receiving annual reports and updates from management. A Senior Director of Information and Cyber Security, with over **25 years** of experience, is responsible for managing cybersecurity risks[612](index=612&type=chunk)[614](index=614&type=chunk) - To date, no known cybersecurity threats or incidents have materially affected the company's operations, business strategy, or financial condition[611](index=611&type=chunk) [Properties](index=197&type=section&id=Item%202.%20Properties) Metsera's principal office is leased at **3 World Trade Center, New York**, under a shared arrangement expiring in **November 2026**, deemed sufficient for current needs - Metsera's principal office is leased under a shared space arrangement at **3 World Trade Center, New York, NY**, with the lease expiring on **November 30, 2026**[617](index=617&type=chunk) Part II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=198&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Metsera's common stock began trading on Nasdaq in **January 2025**, following **$398 million** in 2024 private placements and a **$288.4 million** IPO in **February 2025**, with no dividends planned - The company's common stock began trading on the Nasdaq Global Select Market on **January 31, 2025**, under the symbol "**MTSR**"[622](index=622&type=chunk) - In 2024, the company issued an aggregate of **$398 million** in Series A, A-1, and B preferred stock through private placements to accredited investors[625](index=625&type=chunk)[626](index=626&type=chunk)[627](index=627&type=chunk) - The company completed its IPO on **February 3, 2025**, selling **17,569,444 shares** at **$18.00 per share**, resulting in net proceeds of approximately **$288.4 million**[631](index=631&type=chunk)[633](index=633&type=chunk) - The company has never declared or paid cash dividends and intends to retain future earnings to support operations[624](index=624&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations (MD&A)](index=201&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Metsera reported a **$209.1 million net loss** in 2024, driven by increased R&D and contingent consideration, with **$352.4 million cash** at year-end, sufficient to fund operations into 2027 - The company believes its existing cash and cash equivalents, including IPO proceeds, are sufficient to fund operations into **2027**[642](index=642&type=chunk)[679](index=679&type=chunk) Results of Operations Comparison (in thousands) | | Year ended December 31, 2024 | Year ended December 31, 2023 | $ Change | | :--- | :--- | :--- | :--- | | **Total operating expenses** | $224,833 | $43,669 | $181,164 | | Research and development | $107,517 | $15,564 | $91,953 | | General and administrative | $26,797 | $15,042 | $11,755 | | Change in fair value of contingent consideration | $90,429 | $2,884 | $87,545 | | **Loss from operations** | ($224,833) | ($43,669) | ($181,164) | | **Net loss** | **($209,127)** | **($47,206)** | **($161,921)** | Cash Flow Summary (in thousands) | | Year ended December 31, 2024 | Year ended December 31, 2023 | | :--- | :--- | :--- | | Cash used in operating activities | ($100,039) | ($35,393) | | Cash used in investing activities | ($43) | ($28,242) | | Cash provided by financing activities | $378,198 | $123,683 | | **Net increase in cash and cash equivalents** | **$277,252** | **$60,215** | [Results of Operations](index=206&type=section&id=Results%20of%20Operations) Operating expenses surged to **$224.8 million** in 2024, primarily due to a **$91.9 million increase in R&D** and a **$90.4 million non-cash charge** for contingent consideration - Research and development expenses increased by **$91.9 million** to **$107.5 million** in 2024, primarily due to the ramp-up of preclinical, clinical, and manufacturing activities for the company's injectable and oral programs[664](index=664&type=chunk) - General and administrative expenses increased by **$11.8 million** to **$26.8 million** in 2024, driven by a **$5.5 million** increase in professional fees for IPO preparation and a **$4.8 million** increase in personnel-related costs[666](index=666&type=chunk) - A **$90.4 million** expense was recognized for the change in fair value of contingent consideration, primarily due to the pursuit of a new product and an increased probability of success for milestones related to the Zihipp acquisition[667](index=667&type=chunk) [Liquidity and Capital Resources](index=207&type=section&id=Liquidity%20and%20Capital%20Resources) Metsera held **$352.4 million cash** at year-end 2024, bolstered by a **$288.4 million IPO** in 2025, with **$100.0 million cash used in operations** for 2024 - The company had cash and cash equivalents of **$352.4 million** as of December 31, 2024[673](index=673&type=chunk) - In February 2025, the company completed its IPO, raising net proceeds of **$288.4 million**[673](index=673&type=chunk) - Cash used in operating activities was **$100.0 million** for the year ended December 31, 2024, compared to **$35.4 million** in 2023[681](index=681&type=chunk)[682](index=682&type=chunk) - Net cash provided by financing activities was **$378.2 million** in 2024, mainly from the sale of Series A, A-1, and B convertible preferred stock[684](index=684&type=chunk) [Contractual Obligations and Commitments](index=213&type=section&id=Contractual%20Obligations%20and%20Commitments) Metsera's contractual obligations include **$1.5 million in lease commitments**, significant contingent payments for acquisitions and licenses, and a **$100 million commitment** for an Amneal manufacturing facility - As of December 31, 2024, the company had future minimum lease commitments of **$1.5 million** for office space[687](index=687&type=chunk) - The company has contingent payment obligations from the Zihipp acquisition, including up to **$52.5 million** for initial development milestones and up to **$30.0 million** for initial regulatory milestones, plus royalties[690](index=690&type=chunk) - Under the D&D license agreement, D&D is eligible for up to **$123.0 million** in development/regulatory milestones and up to **$337.5 million** in commercial milestones, plus royalties[814](index=814&type=chunk) - The Amneal supply agreement requires Metsera to finance up to **$100.0 million** for the construction of a new manufacturing facility in India[821](index=821&type=chunk) [Financial Statements and Supplementary Data](index=223&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Audited financial statements show **$451.0 million in total assets** and a **$209.1 million net loss** for 2024, with **$352.4 million in cash and equivalents** Key Financial Data (Year Ended Dec 31, 2024) | Metric | Amount (in thousands) | | :--- | :--- | | **Balance Sheet (as of Dec 31, 2024)** | | | Cash and cash equivalents | $352,447 | | Total Assets | $450,988 | | Total Liabilities | $163,638 | | Accumulated Deficit | ($257,146) | | **Statement of Operations (Year 2024)** | | | Research and Development Expense | $107,517 | | General and Administrative Expense | $26,797 | | Net Loss | ($209,127) | | **Statement of Cash Flows (Year 2024)** | | | Net cash used in operating activities | ($100,039) | | Net cash provided by financing activities | $378,198 | Part III [Directors, Executive Officers and Corporate Governance](index=257&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance) Metsera's leadership includes key executives and a Board with Audit, Compensation, and Nominating committees, guided by a Code of Business Conduct and Ethics - The executive team is led by **Clive A. Meanwell, M.B., Ch.B., M.D.** (Executive Chairman) and **Christopher Whitten Bernard** (President, CEO, and Director)[865](index=865&type=chunk)[866](index=866&type=chunk)[867](index=867&type=chunk) - The Board has established **Audit**, **Compensation**, and **Nominating and Corporate Governance** committees[876](index=876&type=chunk) - The Audit Committee members are **Joshua Pinto, Ph.D.** (Chair), **Kristina M. Burow**, and **Paul L. Berns**. Mr. Pinto is designated as the 'audit committee financial expert'[878](index=878&type=chunk) [Executive Compensation](index=262&type=section&id=Item%2011.%20Executive%20Compensation) 2024 executive compensation for NEOs, led by CEO Christopher Bernard at **$5.97 million**, primarily comprised of stock options and **100%** target bonuses, with new 2025 equity plans adopted 2024 Summary Compensation Table (in $) | Name and Principal Position | Salary | Bonus | Option Awards | Total | | :--- | :--- | :--- | :--- | :--- | | Christopher Whitten Bernard (President & CEO) | 521,538 | 241,644 | 5,206,040 | 5,969,222 | | Clive A. Meanwell, M.B., Ch.B., M.D. (Executive Chairman) | 83,077 | 59,836 | 1,716,704 | 1,859,617 | | Christopher Visioli (CFO, CBO) | 102,308 | 190,000 | 2,746,711 | 3,039,019 | | Brian Hubbard, Ph.D. (CSO) | 401,539 | 181,430 | 613,963 | 1,196,932 | | Gbola Amusa, M.D. (Former CFO) | 363,462 | 133,336 | 1,255,355 | 1,752,153 | - Discretionary annual cash bonuses for 2024 were approved at **100%** of each NEO's target bonus based on company performance[891](index=891&type=chunk)[897](index=897&type=chunk) - The company adopted a new **2025 Incentive Award Plan** and a **2025 Employee Stock Purchase Plan (ESPP)** following its IPO, ceasing new grants under the 2023 Plan[905](index=905&type=chunk)[925](index=925&type=chunk)[938](index=938&type=chunk) [Security Ownership](index=283&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) As of March 7, 2025, Metsera's ownership is concentrated, with ARCH Venture Partners holding **25.5%**, Validae Health **12.2%**, FMR LLC **10.5%**, and all executive officers and directors holding **39.2%** collectively Security Ownership of 5%+ Beneficial Owners and Management (as of March 7, 2025) | Name of Beneficial Owner | Percentage Ownership | | :--- | :--- | | Entities Affiliated with ARCH Venture Partners | 25.5% | | Validae Health, L.P. | 12.2% | | Entities Affiliated with FMR LLC | 10.5% | | All current executive officers and directors as a group (8 persons) | 39.2% | [Related Party Transactions and Director Independence](index=285&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence) Metsera engaged in related party transactions, including **$6.1 million** paid to Validae Health in 2024, with key investors participating in financings, and the Board affirming independence of certain directors - The company has a services agreement with **Validae Health, L.P.**, an entity affiliated with Executive Chairman **Dr. Meanwell** and CEO **Mr. Bernard**. Metsera paid Validae **$6.1 million** in fees and reimbursements in 2024[977](index=977&type=chunk) - Entities affiliated with **ARCH Venture Partners**, where directors **Paul Berns** and **Kristina Burow** are managing directors, participated significantly in the Series Seed, A, and B preferred stock financings[973](index=973&type=chunk) - The Board of Directors has determined that **Paul L. Berns**, **Kristina M. Burow**, and **Joshua Pinto, Ph.D.** are independent directors under Nasdaq rules[980](index=980&type=chunk) [Principal Accountant Fees and Services](index=288&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Ernst & Young LLP provided accounting services, with total fees of **$1,300,000** in 2024, including **$1,260,000** for audit services and **$40,000** for tax services, all pre-approved by the Audit Committee Accountant Fees (2024 vs 2023) | Fee Category | 2024 | 2023 | | :--- | :--- | :--- | | Audit Fees | $1,260,000 | $480,000 | | Tax Fees | $40,000 | $0 | | **Total Fees** | **$1,300,000** | **$480,000** |

[Metsera Q4 and Full Year 2024 Financial Results and Portfolio Update](index=1&type=section&id=Metsera%20Reports%20Fourth%20Quarter%20and%20Full%20Year%202024%20Financial%20Results%20and%20Continued%20Portfolio%20Progress) Metsera advanced its clinical pipeline for obesity and metabolic diseases, including MET-097i into Phase 2b, and secured $316.2 million from an IPO, extending its financial runway into 2027 [Overview](index=1&type=section&id=Overview) Metsera reported significant progress in its clinical pipeline for obesity and metabolic diseases in 2024, highlighted by the advancement of its GLP-1 RA injectable, MET-097i, into Phase 2b trials. The company also initiated clinical trials for its amylin analog (MET-233i) and a prototype oral peptide. A successful IPO in early 2025 raised approximately $316.2 million, extending the company's financial runway into 2027 - Successfully completed an Initial Public Offering (IPO) with gross proceeds of approximately **$316.2 million**, extending the company's operational runway into **2027**[1](index=1&type=chunk)[3](index=3&type=chunk)[8](index=8&type=chunk) - Advanced MET-097i, a monthly GLP-1 RA injectable, through a Phase 2a trial and fully enrolled a Phase 2b trial in **2024**[2](index=2&type=chunk) - Key clinical data readouts are expected in mid-to-late **2025** for MET-097i, MET-233i, and MET-224o[1](index=1&type=chunk) [Pipeline Highlights and Upcoming Milestones](index=1&type=section&id=Pipeline%20Highlights%20and%20Upcoming%20Milestones) The company's pipeline highlights include rapid advancement of MET-097i towards Phase 3, progress in amylin analog and oral peptide programs, and initiation of a MET-097i prodrug [MET-097i (GLP-1 RA)](index=1&type=section&id=MET-097i%20(GLP-1%20RA)) MET-097i, a monthly injectable GLP-1 receptor agonist, is rapidly advancing toward Phase 3. Positive Phase 2a data showed significant weight loss (up to 11.3% placebo-subtracted) and supported a monthly dosing schedule. Multiple Phase 2b trials (VESPER-1, -2, -3) are underway to further evaluate its efficacy and tolerability, with preliminary data from VESPER-1 expected in mid-2025. A Phase 3 program is planned for late 2025 - Topline Phase 2a data demonstrated up to **11.3%** mean placebo-subtracted weight loss after 12 weekly doses, with no plateau observed[3](index=3&type=chunk) - The VESPER-1 Phase 2b trial, evaluating titration-free weekly doses, completed enrollment in December **2024**, with preliminary data expected in mid-**2025**[6](index=6&type=chunk) - The VESPER-3 Phase 2b trial is planned to evaluate monthly dosing, with preliminary results expected by year-end **2025** or early **2026**[6](index=6&type=chunk) - Pending positive Phase 2b results, the company plans to initiate a Phase 3 program for MET-097i in late **2025**[6](index=6&type=chunk) [MET-233i (Amylin Analog)](index=2&type=section&id=MET-233i%20(Amylin%20Analog)) MET-233i, a monthly injectable amylin analog, is progressing through Phase 1 studies. Pharmacokinetic data support its potential for monthly combination therapy with MET-097i. Preliminary efficacy and tolerability data from the multiple ascending dose (MAD) study are expected in mid-2025, with data from a combination study with MET-097i anticipated in late 2025 - MET-233i is designed as a monthly, ultra-long acting amylin analog combinable with MET-097i[6](index=6&type=chunk) - Preliminary 4-week efficacy and tolerability data from the multiple ascending dose (MAD) study are expected in mid-**2025**[4](index=4&type=chunk)[6](index=6&type=chunk) - A combination Phase 1 study for MET-233i and MET-097i is planned, with preliminary data expected in late **2025**[6](index=6&type=chunk) [Oral Peptide Platform (MET-224o & MET-097o)](index=2&type=section&id=Oral%20Peptide%20Platform%20(MET-224o%20%26%20MET-097o)) The company is developing oral GLP-1 receptor agonists, MET-224o and MET-097o. An ongoing Phase 1 formulation optimization study is on track to support the initiation of clinical trials for these candidates. Preliminary 4-week efficacy and tolerability data for MET-224o are expected in late 2025 - MET-224o and MET-097o are oral, fully biased, ultra-long acting GLP-1 RAs in development[6](index=6&type=chunk) - Preliminary 4-week efficacy and tolerability data for MET-224o are expected in late **2025**[5](index=5&type=chunk)[6](index=6&type=chunk) [MET-815i (Prodrug of MET-097i)](index=3&type=section&id=MET-815i%20(Prodrug%20of%20MET-097i)) Metsera has initiated IND-enabling studies for MET-815i, a prodrug of MET-097i. This candidate is designed to smooth drug exposure and prolong its clinical effect, potentially allowing for less frequent dosing and improved tolerability - MET-815i is a prodrug of MET-097i designed to offer less frequent dosing and improved tolerability[7](index=7&type=chunk) [Business and Financial Highlights](index=3&type=section&id=Business%20and%20Financial%20Highlights) Metsera completed a successful IPO in February 2025, raising $316.2 million, and reported increased R&D expenses and a net loss of $209.1 million for full year 2024 [Recent Business Highlights](index=3&type=section&id=Recent%20Business%20Highlights) In February 2025, Metsera successfully completed its initial public offering (IPO), raising significant capital to fund its ongoing and future operations - Completed an IPO in February, raising approximately **$316.2 million** in gross proceeds before expenses[8](index=8&type=chunk) [Full Year 2024 Financial Results](index=3&type=section&id=Full%20Year%202024%20Financial%20Results) For the full year 2024, Metsera's financial results reflect its transition into a clinical-stage company with increased R&D and G&A spending. The company ended the year with a strong cash position of $352.4 million, which, combined with IPO proceeds, is expected to fund operations into 2027. The net loss for the year was $209.1 million, a significant increase from $47.2 million in 2023, driven by higher clinical development costs and a non-cash charge related to the fair value of contingent consideration Cash, Cash Equivalents and Marketable Securities | Financial Metric | 2024 (in millions) | 2023 (in millions) | | :--- | :--- | :--- | | Cash, cash equivalents and marketable securities | $352.4 | $75.2 | - Current cash position, together with net proceeds from the IPO, is estimated to be sufficient to fund operations into **2027**[9](index=9&type=chunk) R&D and G&A Expenses | Expense Category (Full Year) | 2024 (in millions) | 2023 (in millions) | | :--- | :--- | :--- | | R&D Expenses | $107.5 | $15.6 | | G&A Expenses | $26.8 | $15.0 | R&D and G&A Expenses (Q4) | Expense Category (Q4) | Q4 2024 (in millions) | Q4 2023 (in millions) | | :--- | :--- | :--- | | R&D Expenses | $38.9 | $7.6 | | G&A Expenses | $9.7 | $3.6 | - The change in fair value of contingent consideration increased to **$90.4 million** for FY **2024** from **$2.9 million** in FY **2023**, primarily due to the inclusion of a new product and an increased probability of success related to the **2023** Zihipp acquisition[12](index=12&type=chunk) Profitability | Profitability (Full Year) | 2024 | 2023 | | :--- | :--- | :--- | | Net Loss (in millions) | ($209.1) | ($47.2) | | Net Loss Per Share | ($14.49) | ($3.48) | [Financial Statements](index=6&type=section&id=Financial%20Statements) Metsera's 2024 financial statements show increased assets and liabilities, with a net loss of $209.1 million, reflecting significant R&D and contingent consideration expenses [Consolidated Balance Sheets](index=6&type=section&id=CONSOLIDATED%20BALANCE%20SHEETS) As of December 31, 2024, Metsera's total assets increased to $451.0 million from $168.8 million in 2023, primarily driven by a significant rise in cash and cash equivalents. Total liabilities grew to $163.6 million from $70.3 million, largely due to increased accounts payable, accrued expenses, and long-term contingent consideration. The company reported a total stockholders' deficit of $253.5 million Balance Sheet Summary | Financial Metric | Dec 31, 2024 (in thousands) | Dec 31, 2023 (in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $352,447 | $75,195 | | Total current assets | $359,133 | $76,804 | | Total assets | $450,988 | $168,841 | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $67,307 | $20,169 | | Contingent consideration, long-term | $87,850 | $32,500 | | Total liabilities | $163,638 | $70,340 | | Total stockholders' deficit | ($253,507) | ($45,182) | | Total liabilities, redeemable convertible preferred stock and stockholders' deficit | $450,988 | $168,841 | [Consolidated Statement of Operations and Comprehensive Loss](index=7&type=section&id=CONSOLIDATED%20STATEMENT%20OF%20OPERATIONS%20AND%20COMPREHENSIVE%20LOSS) For the year ended December 31, 2024, Metsera reported a net loss of $209.1 million, compared to a net loss of $47.2 million in 2023. The increased loss was primarily due to a substantial rise in R&D expenses to $107.5 million and a $90.4 million charge for the change in fair value of contingent consideration. For the fourth quarter of 2024, the net loss was $52.9 million, up from $13.0 million in the same period of 2023 Statement of Operations (Full Year) | Expense Category | Year ended Dec 31, 2024 | Year ended Dec 31, 2023 | | :--- | :--- | :--- | | Research and development (in thousands) | $107,517 | $15,564 | | General and administrative (in thousands) | $26,797 | $15,042 | | Change in fair value of contingent consideration (in thousands) | $90,429 | $2,884 | | **Total operating expenses (in thousands)** | **$224,833** | **$43,669** | | Loss from operations (in thousands) | ($224,833) | ($43,669) | | Interest income (in thousands) | $6,185 | $1,918 | | **Net loss (in thousands)** | **($209,127)** | **($47,206)** | | Net loss per share, basic and diluted | ($14.49) | ($3.48) | Statement of Operations (Q4) | Expense Category | Q4 2024 | Q4 2023 | | :--- | :--- | :--- | | Total operating expenses (in thousands) | $64,500 | $13,873 | | **Net loss (in thousands)** | **($52,871)** | **($13,029)** | | Net loss per share, basic and diluted | ($3.52) | ($0.94) | [Company Information and Disclosures](index=4&type=section&id=Company%20Information%20and%20Disclosures) Metsera, a clinical-stage biopharmaceutical company, provides information on its focus on obesity and metabolic diseases, alongside disclosures on forward-looking statements and associated risks [About Metsera](index=4&type=section&id=About%20Metsera) Metsera is a clinical-stage biopharmaceutical company founded in 2022 and based in New York City. The company focuses on accelerating the development of next-generation oral and injectable medicines for obesity and metabolic diseases, advancing a broad portfolio of therapies targeting multiple pathways - Metsera is a clinical-stage biopharmaceutical company focused on developing next-generation medicines for obesity and metabolic diseases[14](index=14&type=chunk) [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This press release contains forward-looking statements regarding clinical trial timelines, pipeline milestones, market strategy, and financial projections. These statements are based on current expectations and are subject to inherent uncertainties and risks. Actual results could differ materially, and the company disclaims any obligation to update these statements - The report includes forward-looking statements concerning clinical trial timelines, product pipeline events, and future financial results, which are subject to risks and uncertainties[16](index=16&type=chunk) - The company cautions that actual results could differ materially from those implied by forward-looking statements and directs readers to its SEC filings for a discussion of risk factors[17](index=17&type=chunk)